Reducing Children's Anxiety Using Homeopathic Remedy Before Dental Treatment

NCT01658059 | Completed Results

• 1 other identifier: rcauhr-HMO-CTIL
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacological interventions to aid behavior management's techniques are commonly used in pediatric dentistry. The aim of the medicaments is to control behavior and allow safe completion of a dental procedure. Homeopathic remedy is safe and can be effective to control behavior and decrease anxiety in children during dental treatment. Aim: 1. To explore the efficacy of homeopathic drugs in decreasing children's dental anxiety before dental treatment. 2\. To assess the effectiveness of homeopathic remedy in facilitating dental treatment for anxious children. Methods: prospective, double-blind study. Thirty healthy children (5-12 years-old) will receive homeopathic remedy\\placebo before dental treatment. Anxiety reduction will be measured using: saliva cortisol levels, saliva α-amylase levels, facial image scale (FIS), and Houpt behavior scale. Expected results: the homeopathic remedy will reduce anxiety and increase child cooperation during dental treatment.

Conditions

Children's Dental Anxiety

Outcome Measures

Primary Outcomes (1)

• Reducing Children's Anxiety

  Measuring levels of salivary cortisol and salivary α-amylase levels before dental treatment and after dental treatment .

  Each dental apointment, aproximatly 30 minutes on the average

Study Arms (2)

group 1

EXPERIMENTAL

homeopathic remedy first , placebo second

Other: Homeopathic remedy; Other: Placebo

group 2

EXPERIMENTAL

placebo first, homeopathic remedy second

Other: Homeopathic remedy; Other: Placebo

Interventions

Homeopathic remedy OTHER

drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.

group 1; group 2

Placebo OTHER

drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.

group 1; group 2

Eligibility Criteria

• Age: 5 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Dental anxiety
• Needs at least 2 dental treatment appointments

You may not qualify if:

• Medically compromised
• Cooperative, needs less than 2 dental treatment appointments

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Hadassah Medical Organization

Jerusalem, 91120, Israel

Location

MeSH Terms

Interventions

Homeopathy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Results Point of Contact

• Title: Moti Moskovitz
• Organization: Hadassah Medical Organization

motim@ekmd.huji.ac.il

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical senior lecturer, department of pediatric dentistry

Study Record Dates

• First Submitted: July 21, 2012
• First Posted: August 6, 2012
• Study Start: September 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2015
• Last Updated: March 20, 2019
• Results First Posted: March 11, 2019

Record last verified: 2019-03

Locations

IL (1)